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PF-04895162

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Mar 28, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

PF-04895162 · 1 trial · 1 indication

Phase 1 1
NCT01691274A Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Multiple Oral Doses Of PF-04895162Healthy
COMPLETED10 Analytics
PHASE1COMPLETED
A Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Multiple Oral Doses Of PF-04895162
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum observed plasma concentration (Cmax)
up to 12 h post dose for Days 1, 7 and 14
Time of maximum concentration (Tmax)
up to 12 h post dose for Days 1, 7 and 14
Area under the plasma concentration time profile from time zero extrapolated to inifinite time (AUCinf)
up to 12 h post dose for Days 1, 7 and 14
Area under the plasma concentration time profile from time zero to the time of last quantifiable concentration (AUClast)
up to 12 h post dose for Days 1, 7 and 14
Area under the plasma concentration time profile from time zero to quantifiable concentration 24 h post dose (AUC24)
up to 12 h post dose for Days 1, 7 and 14
AUCtau= Area under the curve from the time of dosing to the next dose (ng.hr/mL)
up to 12 h post dose for Days 1, 7 and 14
t1/2 = Terminal Elimination half life
up to 12 h post dose for Days 1, 7 and 14
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
PF-04895162EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PF-04895162DRUGTablets, 300 mg, single, 1 day
PlaceboDRUGTablets, twice a day, 14 days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy male and/or female subjects of non-child bearing potential between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and puls...

Countries:United States
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Frequently asked questions about PF-04895162

What is PF-04895162 used for?

PF-04895162 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is in clinical development to evaluate its safety, toleration, and plasma concentration profile. The drug is being developed by Pfizer, Inc. (PFE).

What does PF-04895162 target?

The molecular target of PF-04895162 has not been disclosed. It is a small molecule in Phase 1 clinical development, but its specific mechanism of action is not publicly available from the trial information provided.

Who makes PF-04895162?

PF-04895162 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in healthy participants.

What phase is PF-04895162 in?

PF-04895162 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains under evaluation for its safety and toleration profile.

What clinical trials is PF-04895162 in?

PF-04895162 has one completed Phase 1 trial, NCT01691274, which evaluated the safety, toleration, and plasma concentration of multiple oral doses in healthy adults. The trial enrolled 10 participants in the United States and was randomized, double-blind, and placebo-controlled.